Valganciclovir Therapy in Infants and Children With Congenital CMV Infection and Hearing Loss

Completed · Phase 2 · Has a placebo group

Conditions studied: Cytomegalovirus Infection

In brief

This is an international, multi-center, double-blind, placebo-controlled evaluation valganciclovir treatment for up to 54 children (up to 4 years of age) with virologically-confirmed congenital CMV infection and hearing loss. Subject participation will be over a six-month period and study subjects will be stratified according to age. The primary objective is to assess whether a six-week course of oral valganciclovir can stabilize the hearing of children with congenital CMV infection who present with hearing loss.

Key facts

Study ID

NCT01649869

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

54

Starts

2015-02-24

Expected to finish

2019-12-24

Last updated by the study team

2024-10-16

Who can join

Age: 0 and older, up to 4. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent from parent(s) or legal guardian(s)
• Sensorineural hearing loss (>/= 21dB in one or both ears, documented within 12 weeks prior to study entry)
• Children from 1 month through 3 years of age (up to the 4th birthday)

You may not qualify if…

• Imminent demise
• Profound sensorineural hearing loss (> 90dB) in both ears
• Patients receiving other antiviral agents or immune globulin
• Gastrointestinal abnormality which might preclude absorption of an oral medication (e.g., a history of necrotizing enterocolitis)
• Documented renal insufficiency, as noted by a creatinine clearance < 10 mL/min/1.73m2 at time of study enrollment
• Breastfeeding from mother who is receiving ganciclovir, valganciclovir, foscarnet, cidofovir, or maribavir
• Infants known to be born to women who are HIV positive (but HIV testing is not required for study entry).
• Current receipt of other investigational drugs
• Previous receipt of ganciclovir or valganciclovir
• Known hypersensitivity to ganciclovir, valganciclovir, or components of the product
• Inability to attend follow-up hearing and clinical assessments
• Infants with Auditory neuropathy/dyssynchrony.
• Children with another known etiology for SNHL (e.g. connexin 26, syndrome or metabolic disorder associated with SNHL, inner ear malformation and widened vestibular aqueducts, meningitis).
• Exclusion of each of these conditions is not required for trial enrollment.

Where it is running

• Children's of Alabama Child Health Research Unit (CHRU) — Birmingham, Alabama, United States
• Children's National Medical Center - Sheikh Zayed Campus - Infectious Disease — Washington D.C., District of Columbia, United States
• Washington University School of Medicine in St. Louis - Center for Clinical Studies — St Louis, Missouri, United States
• Steven and Alexandra Cohen Childrens Medical Center of New York - New Hyde Park - Infectious Disease — Manhasset, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Carolinas Medical Center - Pediatrics - Infectious Diseases — Charlotte, North Carolina, United States
• Nationwide Children's Hospital - Neonatology - Center for Perinatal Research — Columbus, Ohio, United States
• Rhode Island Hospital - Pediatrics — Providence, Rhode Island, United States
• Texas Medical Center - Texas Children's Hospital — Houston, Texas, United States
• Bristol Royal Hospital for Children - Paediatric Immunology — Bristol, Bristol, City of, United Kingdom
• Saint George's Hospital - Pediatric Infectious Diseases — London, London, City of, United Kingdom
• Great Ormond Street Hospital - Infectious Diseases — London, London, City of, United Kingdom
• Birmingham Heartlands Hospital — Birmingham, United Kingdom
• Pennine Acute Hospitals NHS Trust, North Manchester General Hospital - Children's and Adolescent Services — Crumpsall, United Kingdom
• John Radcliffe Hospital - Children's Hospital - Paediatric Infectious Disease and Immunology — Headington, Oxford, United Kingdom
• The Great North Children's Hospital - Paediatric Immunology — Newcastle upon Tyne, United Kingdom
• Sheffield Children's Hospital - Immunology — Sheffield, United Kingdom
• Southampton Children's Hospital - Allergy, Immunology and Infection — Southampton, Hampshire, United Kingdom

Full record on ClinicalTrials.gov

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